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Cardio Selfcare  International Innovative Selfcare Products and Services in Cardiology and Thrombosis GLOBAL INTRODUCTION STRATEGY SEARCH FOR DISTRIBUTORS Cardio Selfcare International will be present at MEDICA, Dutch Pavilion, Hall 17, Booth C04
Search for Distributors The approach is dead simple Cardio Selfcare International has a portfolio of 4 Products and Services for the cardiovascular self management market. The distributor who purchases a fixed number of ThromboCheck® becomes the 1st year exclusive partner for his territory for the total portfolio of  Cardio Selfcare International. This exclusivity is continued as long as results are mutually satisfactory. Dead simple: 	Commitment is balanced by exclusivity.
Content 4-5 6-15 16-18 19-22 23-24 25-33 34-39 40 Cardio Selfcare International. ThromboCheck®. ThromboCheck Pro®. Virtual Thrombosis Service®. Tephos ®.  Business Strategy Distribution Strategy. Contact details.
Cardio Selfcare International A. General background Dutch company, division of External Brain(s) Ltd (since 1992). Portfolio of innovative self management products and services for patients with a cardiovascular condition or risk. First products on the market in Holland and Germany. Looking to set up its international distributor network.
Cardio Selfcare International B. Products & Services ThromboCheck® ThromboCheck Pro® Virtual Thrombosis Service® Tephos® Controlling the MechanicalHeartValveProsthesis Thrombosis Self Monitoring and Management Controlling Instable Heart Failure
1.	ThromboCheck® 	A. General background Application: 	Handheld device, to be placed on chest for 1 minute. Mode of action: Analysis of mechanical heart valve sounds. Feedback: “OK”, “Repeat”, “Not OK”. In case of “Not OK”, follow-up depending on service package. Relevance: Problems occur in 1-6% per patient per year. Any kind of dysfunctioningof the mechanical heart valve  detected at very early stage. Controlling the Mechanical Heart Valve Prosthesis
1.	ThromboCheck® 	A. General background Causes: Thrombosis (most common), tissue in-growth, inflammation. Consequences: Leakage of the valve, mostly evolving into heart failure. Thrombo-embolism, mostly leading to cerebral infarction.  Threat: Often deadly or leading to serious disabilities. Value: Detection leads to window for treatment, preventing the expected devastating complications and saving massive healthcare costs. Controlling the Mechanical Heart Valve Prosthesis
1.	ThromboCheck® 	A. General background Important clinical innovation. Available as self management device. Easier, faster, cheaper as compared to available hospital technologies. Sensitivity  100%, specificity > 95%. Clinical value proven in daily practice. Reliable monitoring through an easy 1-minute procedure. Controlling the Mechanical Heart Valve Prosthesis
1.	ThromboCheck® 	B. Technical background Co-operation between Physics Department University of Wiesbaden (Prof. Dr. A. Brensing), Germany. Commercial enterprise in Hamburg, Germany. Worldwide patents filed. CE mark Controlling the Mechanical Heart Valve Prosthesis
1.	ThromboCheck® 	C. Clinical background > 5 years in clinical use in Germany’s biggest cardiology center, Bad Oeynhausen (Prof. Dr. D. Fritzsche). > 1.500 valve patients monitored up to 4 years. Mechanical valve thrombosis detected in 3,0 – 4,5% per year. Many patients saved due to early detection.  Results published in several medical journals. Controlling the Mechanical Heart Valve Prosthesis
1.	ThromboCheck® 	D. What is visualized? Controlling the Mechanical Heart Valve Prosthesis Leaflet1 Leaflet2 Opening sound Closing sound Hinge 1 Hinge 2
1.	ThromboCheck® 	E. Typical example Controlling the Mechanical Heart Valve Prosthesis
1.	ThromboCheck® 	F. Market background Netherlands = reference country. Minimum potential is calculated with the assumptions given in the model (yellow cells):  Controlling the Mechanical Heart Valve Prosthesis Minimum world market potential by end 2013: 140.000 units
1.	ThromboCheck® 	G. Commercial proposition Buying price local distributor		€ 400 Gross selling price local distributor	€ 700 (value added: 75%)   c ThromboCheck® only. In case of WARNING, patient takes contact with his cardiologist. Controlling the Mechanical Heart Valve Prosthesis
1.	ThromboCheck® 	H. Services with recurrent income Telemetric supervision. Emergency cardiology involvement. Patient e-learning and information services. 30% of ThromboCheck®users will purchase the service package. Service package value € 300 per year (patient price). Controlling the Mechanical Heart Valve Prosthesis
2.	ThromboCheck Pro® 	A. General background Comparable product. Developed for cardiologist, cardio surgeon, intensivist. Instant diagnosis regarding condition of mechanical heart valve prosthesis. Faster, easier, cheaper and more reliable as compared to transthoracal or transesophagal echography and fluoroscopy. Applicable in any clinical situation where a patient expresses signs or symptoms that may involve valve dysfunction. Controlling the Mechanical Heart Valve Prosthesis
2.	ThromboCheck Pro® 	B. Market background Number of cardiologists varies from 10/106in  Ireland to 200/106 in Argentina. Withanaverage of 50/106 and 10-fold discount, the minimum potential for ThromboCheck Pro®amounts to 29.000. Not taken into consideration: Cardio surgeons. Cardiology units. Coronary care units. Intensive care units. General surgical units. Controlling the Mechanical Heart Valve Prosthesis
2.	ThromboCheck Pro® 	C. Commercial proposition Buying price local distributor		€ 800 Gross selling price local distributor      € 1.200 (value added: 50%)    c Recurrent annual service package of € 200 -     € 800, average € 400 (medical specialist price). Controlling the Mechanical Heart Valve Prosthesis
3.	Virtual Thrombosis Service® 	A. Reason of existence Thrombosis is the most important underlying cause of mechanical valve complications. Therefore the vast majority of patients with a mechanical heart valve is – or should be – using anticoagulation medication.  If using anticoagulation, blood must be monitored biweekly to maintain the proper coagulation ability (INR value or Quick Index). Consequences of being out-of-range: Life-threatening thrombotic complications (myocardial infarction, pulmonary embolism, stroke). Life-threatening bleeding complications (stroke). Thrombosis Self Monitoring and Management
3.	Virtual Thrombosis Service® 	B. Clinical content and services Electronic Patient Record for Thrombosis Self Management. Self monitoring of INR value through finger prick (similar to glucose approach). Tele-supervision of INR. Tele-provision of required daily anticoagulation dosages. 24/7 Medical supervision. Patient e-learning and information services. Compliance support services. Thrombosis Self Monitoring and Management
3.	Virtual Thrombosis Service® 	C. Track record Developed in The Netherlands. Academic Medical Center, Amsterdam. Technical University, Eindhoven. Cardio Selfcare Netherlands, Ede. In controlled clinical use for 4 years. Stability and quality proven in > 3.000 patient years. Audited by Dutch Health Authorities. Fully reimbursed by health insurance. Positively evaluated in prospective, parallel clinical trial vs. conventional thrombosis care. Thrombosis Self Monitoring and Management
3.	Virtual Thrombosis Service® 	D. Business potential 20% of ThromboCheck®users will purchase the Virtual Thrombosis Service®.  Virtual Thrombosis Service® averages a recurrent € 800 per year (patient price). A much bigger market potential. Relevant to anyone on anticoagulation treatment! Prevalence: 1,5 – 3,0% of total population. Minimum potential customer base:		     7-15 * ThromboCheck®. Thrombosis Self Monitoring and Management
4.	Tephos® 	A. Heart Failure Major medical problem of the elderly with progressive impairing quality of life.  Acute deteriorations with major impact on the patient and very high costs (hospitalization, rehabilitation, etc.). Crucial to monitor hemodynamic condition of late stage patients (NYHA 3 and 4) to prevent these deteriorations. Monitoring however is very cumbersome: Body weight. Fluid balance. Controlling Instable Heart Failure
4.	Tephos® 	B. General background New approach to self monitoring of instable Heart Failure patients. Advanced sound technology to measure changes in LVET (Left Ventricular Ejection Time). Detection of hemodynamic deterioration much earlier compared to current methods. Prevention of acute hospitalization with major on quality of life and medical costs. Tephos® is still in clinical development. 	            Co-financing may qualify for distributorship. Controlling Instable Heart Failure
5.	Business Strategy 	Ground thoughts Cardiovascular market consists of 10-25% of a country’s population. Self management is the only way to contain costs. Estimated 20-50% is willing and able to take active role as self manager. General strategy: penetrate this huge and growing market through successful introduction in market niches.
5.	Business Strategy 	Penetration the barrier to entry thru niches
5.	Business Strategy 	Niche A. Mechanical Heart Valve Small, high impact chronic segment with 1-6% serious complications per patients per year. CSI offering: ThromboCheck®, a unique, patented, hand-held device with superior sensitivity and specificity to detect mechanical valve malfunction. Two products variants: ThromboCheck®  for self monitoring. ThromboCheck Pro® for the medical specialist (cardiologist, cardio surgeon, intensivist).
5.	Business Strategy 	Niche B. Thrombosis Medium sized, low interest segment with a need to maximize self management. CSI offering: Virtual Thrombosis Service®, a stable, proven, user-friendly webbased approach combining self management with central medical supervision.
5.	Business Strategy 	Niche C. Instable Heart Failure Small, but very serious high impact segment with high death rate, massive loss of life quality of and very high costs. CSI offering: Tephos®, a unique, patented, hand-held device with the promise to detect hemodynamic deterioration at a much earlier stage, therefore preventing much of the patient and market burdens. Still to be confirmed in clinical practice.
5.	Business Strategy 	Niche D. General interest in self management The total willing & able segment. CSI offering: cgEPD®, client guided Electronic Personal Dossier, in which neither the patient, nor the doctor, but the client is central.
5.	Business Strategy 	E. The cgEPD® as Trojan Horse To have patients in Niche A/B/C fully benefit from  CSI offerings, they have to make use of the cgEPD®. Once the cgEPD®is in use, it supports self management in: Mechanical Heart Valve / Thrombosis / Heart Failure. Plus: Body weight and BMI. Blood pressure and Oxygen saturation. Glucose and Cholesterol levels. Patientcompliance. Providing accessto reliable indication or medication related information. Providing access to 24/7 Medical Service Center.
5.	Business Strategy 	F. Cross selling Between indication A/B/C and cgEPD®. Between indications: Mechanical Heart Valve and Thrombosis management. Instable Heart Failure and Thrombosis management. Niche A/B/C and Overweight, Hypertension, Diabetes, Dyslipidemia, etc.
5.	Business Strategy 	G. Comparative market sizes (for orientation only) Heart Valve	= 2 Thrombosis	= 25 Heart Failure	= 5 cgEPD®	= 75
6.	Distribution Strategy 	Ground thoughts CSI holds distribution rights for almost all countries worldwide. CSI wants to focus on portfolio development to continue to fuel the portfolio with innovative, unique products and services that will satisfy market needs or fill new niches. Distribution strategy should be dead simple.
6.	Distribution Strategy 	Dead simple Distribution partner in each market who can substantiate: Genuine interest. Relevant network and experience, Appropriate priority related to the CSI portfolio. Distribution partner may cover multiple markets. Mutually rewarding, swift, semi-binding, semi-exclusive business agreements.
6.	Distribution Strategy 	Business agreement Partner buys number of ThromboCheck®units related to territory characteristics. This is an actual purchase. Partner gets exclusive rights for the territory for one year for the full CSI portfolio. Commercial yearly targets are set for the full CSI portfolio. Exclusivity is continuously extended by one year for each of the Products or Services for which the target is met.
6.	Distribution Strategy 	Business agreement
6.	Distribution Strategy 	Mutual commitment CSI obtains from Partner an upfront commitment  ensuring local market activity and continuous central portfolio development. Partner is guaranteed of continuous exclusivity as long as it reaches the goals which are meant to be relevant for both parties involved.
6.	Distribution Strategy 	Exclusivity targets Number of ThromboCheck®clinching first year exclusivity for total CSI portfolio in some reference territories:
7.	Contact details Dr. Rob Neeter CEO Mail:	info@cardioselfcare.com Web:	www.cardioselfcare.com Phone:	 +31653353703 Cardio Selfcare International will be present at MEDICA Dutch Pavillion, Hall 17, Booth C04

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Cardio Selfcare International Distribution Strategy

  • 1. Cardio Selfcare International Innovative Selfcare Products and Services in Cardiology and Thrombosis GLOBAL INTRODUCTION STRATEGY SEARCH FOR DISTRIBUTORS Cardio Selfcare International will be present at MEDICA, Dutch Pavilion, Hall 17, Booth C04
  • 2. Search for Distributors The approach is dead simple Cardio Selfcare International has a portfolio of 4 Products and Services for the cardiovascular self management market. The distributor who purchases a fixed number of ThromboCheck® becomes the 1st year exclusive partner for his territory for the total portfolio of Cardio Selfcare International. This exclusivity is continued as long as results are mutually satisfactory. Dead simple: Commitment is balanced by exclusivity.
  • 3. Content 4-5 6-15 16-18 19-22 23-24 25-33 34-39 40 Cardio Selfcare International. ThromboCheck®. ThromboCheck Pro®. Virtual Thrombosis Service®. Tephos ®. Business Strategy Distribution Strategy. Contact details.
  • 4. Cardio Selfcare International A. General background Dutch company, division of External Brain(s) Ltd (since 1992). Portfolio of innovative self management products and services for patients with a cardiovascular condition or risk. First products on the market in Holland and Germany. Looking to set up its international distributor network.
  • 5. Cardio Selfcare International B. Products & Services ThromboCheck® ThromboCheck Pro® Virtual Thrombosis Service® Tephos® Controlling the MechanicalHeartValveProsthesis Thrombosis Self Monitoring and Management Controlling Instable Heart Failure
  • 6. 1. ThromboCheck® A. General background Application: Handheld device, to be placed on chest for 1 minute. Mode of action: Analysis of mechanical heart valve sounds. Feedback: “OK”, “Repeat”, “Not OK”. In case of “Not OK”, follow-up depending on service package. Relevance: Problems occur in 1-6% per patient per year. Any kind of dysfunctioningof the mechanical heart valve detected at very early stage. Controlling the Mechanical Heart Valve Prosthesis
  • 7. 1. ThromboCheck® A. General background Causes: Thrombosis (most common), tissue in-growth, inflammation. Consequences: Leakage of the valve, mostly evolving into heart failure. Thrombo-embolism, mostly leading to cerebral infarction. Threat: Often deadly or leading to serious disabilities. Value: Detection leads to window for treatment, preventing the expected devastating complications and saving massive healthcare costs. Controlling the Mechanical Heart Valve Prosthesis
  • 8. 1. ThromboCheck® A. General background Important clinical innovation. Available as self management device. Easier, faster, cheaper as compared to available hospital technologies. Sensitivity  100%, specificity > 95%. Clinical value proven in daily practice. Reliable monitoring through an easy 1-minute procedure. Controlling the Mechanical Heart Valve Prosthesis
  • 9. 1. ThromboCheck® B. Technical background Co-operation between Physics Department University of Wiesbaden (Prof. Dr. A. Brensing), Germany. Commercial enterprise in Hamburg, Germany. Worldwide patents filed. CE mark Controlling the Mechanical Heart Valve Prosthesis
  • 10. 1. ThromboCheck® C. Clinical background > 5 years in clinical use in Germany’s biggest cardiology center, Bad Oeynhausen (Prof. Dr. D. Fritzsche). > 1.500 valve patients monitored up to 4 years. Mechanical valve thrombosis detected in 3,0 – 4,5% per year. Many patients saved due to early detection. Results published in several medical journals. Controlling the Mechanical Heart Valve Prosthesis
  • 11. 1. ThromboCheck® D. What is visualized? Controlling the Mechanical Heart Valve Prosthesis Leaflet1 Leaflet2 Opening sound Closing sound Hinge 1 Hinge 2
  • 12. 1. ThromboCheck® E. Typical example Controlling the Mechanical Heart Valve Prosthesis
  • 13. 1. ThromboCheck® F. Market background Netherlands = reference country. Minimum potential is calculated with the assumptions given in the model (yellow cells): Controlling the Mechanical Heart Valve Prosthesis Minimum world market potential by end 2013: 140.000 units
  • 14. 1. ThromboCheck® G. Commercial proposition Buying price local distributor € 400 Gross selling price local distributor € 700 (value added: 75%) c ThromboCheck® only. In case of WARNING, patient takes contact with his cardiologist. Controlling the Mechanical Heart Valve Prosthesis
  • 15. 1. ThromboCheck® H. Services with recurrent income Telemetric supervision. Emergency cardiology involvement. Patient e-learning and information services. 30% of ThromboCheck®users will purchase the service package. Service package value € 300 per year (patient price). Controlling the Mechanical Heart Valve Prosthesis
  • 16. 2. ThromboCheck Pro® A. General background Comparable product. Developed for cardiologist, cardio surgeon, intensivist. Instant diagnosis regarding condition of mechanical heart valve prosthesis. Faster, easier, cheaper and more reliable as compared to transthoracal or transesophagal echography and fluoroscopy. Applicable in any clinical situation where a patient expresses signs or symptoms that may involve valve dysfunction. Controlling the Mechanical Heart Valve Prosthesis
  • 17. 2. ThromboCheck Pro® B. Market background Number of cardiologists varies from 10/106in Ireland to 200/106 in Argentina. Withanaverage of 50/106 and 10-fold discount, the minimum potential for ThromboCheck Pro®amounts to 29.000. Not taken into consideration: Cardio surgeons. Cardiology units. Coronary care units. Intensive care units. General surgical units. Controlling the Mechanical Heart Valve Prosthesis
  • 18. 2. ThromboCheck Pro® C. Commercial proposition Buying price local distributor € 800 Gross selling price local distributor € 1.200 (value added: 50%) c Recurrent annual service package of € 200 - € 800, average € 400 (medical specialist price). Controlling the Mechanical Heart Valve Prosthesis
  • 19. 3. Virtual Thrombosis Service® A. Reason of existence Thrombosis is the most important underlying cause of mechanical valve complications. Therefore the vast majority of patients with a mechanical heart valve is – or should be – using anticoagulation medication. If using anticoagulation, blood must be monitored biweekly to maintain the proper coagulation ability (INR value or Quick Index). Consequences of being out-of-range: Life-threatening thrombotic complications (myocardial infarction, pulmonary embolism, stroke). Life-threatening bleeding complications (stroke). Thrombosis Self Monitoring and Management
  • 20. 3. Virtual Thrombosis Service® B. Clinical content and services Electronic Patient Record for Thrombosis Self Management. Self monitoring of INR value through finger prick (similar to glucose approach). Tele-supervision of INR. Tele-provision of required daily anticoagulation dosages. 24/7 Medical supervision. Patient e-learning and information services. Compliance support services. Thrombosis Self Monitoring and Management
  • 21. 3. Virtual Thrombosis Service® C. Track record Developed in The Netherlands. Academic Medical Center, Amsterdam. Technical University, Eindhoven. Cardio Selfcare Netherlands, Ede. In controlled clinical use for 4 years. Stability and quality proven in > 3.000 patient years. Audited by Dutch Health Authorities. Fully reimbursed by health insurance. Positively evaluated in prospective, parallel clinical trial vs. conventional thrombosis care. Thrombosis Self Monitoring and Management
  • 22. 3. Virtual Thrombosis Service® D. Business potential 20% of ThromboCheck®users will purchase the Virtual Thrombosis Service®. Virtual Thrombosis Service® averages a recurrent € 800 per year (patient price). A much bigger market potential. Relevant to anyone on anticoagulation treatment! Prevalence: 1,5 – 3,0% of total population. Minimum potential customer base: 7-15 * ThromboCheck®. Thrombosis Self Monitoring and Management
  • 23. 4. Tephos® A. Heart Failure Major medical problem of the elderly with progressive impairing quality of life. Acute deteriorations with major impact on the patient and very high costs (hospitalization, rehabilitation, etc.). Crucial to monitor hemodynamic condition of late stage patients (NYHA 3 and 4) to prevent these deteriorations. Monitoring however is very cumbersome: Body weight. Fluid balance. Controlling Instable Heart Failure
  • 24. 4. Tephos® B. General background New approach to self monitoring of instable Heart Failure patients. Advanced sound technology to measure changes in LVET (Left Ventricular Ejection Time). Detection of hemodynamic deterioration much earlier compared to current methods. Prevention of acute hospitalization with major on quality of life and medical costs. Tephos® is still in clinical development. Co-financing may qualify for distributorship. Controlling Instable Heart Failure
  • 25. 5. Business Strategy Ground thoughts Cardiovascular market consists of 10-25% of a country’s population. Self management is the only way to contain costs. Estimated 20-50% is willing and able to take active role as self manager. General strategy: penetrate this huge and growing market through successful introduction in market niches.
  • 26. 5. Business Strategy Penetration the barrier to entry thru niches
  • 27. 5. Business Strategy Niche A. Mechanical Heart Valve Small, high impact chronic segment with 1-6% serious complications per patients per year. CSI offering: ThromboCheck®, a unique, patented, hand-held device with superior sensitivity and specificity to detect mechanical valve malfunction. Two products variants: ThromboCheck® for self monitoring. ThromboCheck Pro® for the medical specialist (cardiologist, cardio surgeon, intensivist).
  • 28. 5. Business Strategy Niche B. Thrombosis Medium sized, low interest segment with a need to maximize self management. CSI offering: Virtual Thrombosis Service®, a stable, proven, user-friendly webbased approach combining self management with central medical supervision.
  • 29. 5. Business Strategy Niche C. Instable Heart Failure Small, but very serious high impact segment with high death rate, massive loss of life quality of and very high costs. CSI offering: Tephos®, a unique, patented, hand-held device with the promise to detect hemodynamic deterioration at a much earlier stage, therefore preventing much of the patient and market burdens. Still to be confirmed in clinical practice.
  • 30. 5. Business Strategy Niche D. General interest in self management The total willing & able segment. CSI offering: cgEPD®, client guided Electronic Personal Dossier, in which neither the patient, nor the doctor, but the client is central.
  • 31. 5. Business Strategy E. The cgEPD® as Trojan Horse To have patients in Niche A/B/C fully benefit from CSI offerings, they have to make use of the cgEPD®. Once the cgEPD®is in use, it supports self management in: Mechanical Heart Valve / Thrombosis / Heart Failure. Plus: Body weight and BMI. Blood pressure and Oxygen saturation. Glucose and Cholesterol levels. Patientcompliance. Providing accessto reliable indication or medication related information. Providing access to 24/7 Medical Service Center.
  • 32. 5. Business Strategy F. Cross selling Between indication A/B/C and cgEPD®. Between indications: Mechanical Heart Valve and Thrombosis management. Instable Heart Failure and Thrombosis management. Niche A/B/C and Overweight, Hypertension, Diabetes, Dyslipidemia, etc.
  • 33. 5. Business Strategy G. Comparative market sizes (for orientation only) Heart Valve = 2 Thrombosis = 25 Heart Failure = 5 cgEPD® = 75
  • 34. 6. Distribution Strategy Ground thoughts CSI holds distribution rights for almost all countries worldwide. CSI wants to focus on portfolio development to continue to fuel the portfolio with innovative, unique products and services that will satisfy market needs or fill new niches. Distribution strategy should be dead simple.
  • 35. 6. Distribution Strategy Dead simple Distribution partner in each market who can substantiate: Genuine interest. Relevant network and experience, Appropriate priority related to the CSI portfolio. Distribution partner may cover multiple markets. Mutually rewarding, swift, semi-binding, semi-exclusive business agreements.
  • 36. 6. Distribution Strategy Business agreement Partner buys number of ThromboCheck®units related to territory characteristics. This is an actual purchase. Partner gets exclusive rights for the territory for one year for the full CSI portfolio. Commercial yearly targets are set for the full CSI portfolio. Exclusivity is continuously extended by one year for each of the Products or Services for which the target is met.
  • 38. 6. Distribution Strategy Mutual commitment CSI obtains from Partner an upfront commitment ensuring local market activity and continuous central portfolio development. Partner is guaranteed of continuous exclusivity as long as it reaches the goals which are meant to be relevant for both parties involved.
  • 39. 6. Distribution Strategy Exclusivity targets Number of ThromboCheck®clinching first year exclusivity for total CSI portfolio in some reference territories:
  • 40. 7. Contact details Dr. Rob Neeter CEO Mail: info@cardioselfcare.com Web: www.cardioselfcare.com Phone: +31653353703 Cardio Selfcare International will be present at MEDICA Dutch Pavillion, Hall 17, Booth C04